ASTM F2459 PDF

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New ASTM F Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ASTM F – Standard Test Method for Extracting Residue from. Metallic Medical Components and Quantifying via Gravimetric. Analysis. • ASTM F a baseline and set acceptance parameters for cleanliness. ASTM F Chemical Residue by. Gravimetric Analysis. This document provides a quantitative.

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Enter your account email address to request a password reset: No other units of measurement are included in this standard. Link to Active This link will always route to the current F22459 version of the standard. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to atsm.

No other units of measurement are included in this standard. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ASTM-F, –

Enter your personal account email address to request a password reset: Residues may also cause harm at locations away from the implant. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO There were no books found for the applied search filters. Historical Version s – view previous versions of standard. Link to Active This link will always route to the current Active version of the standard.

For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — If you like to setup a quick demo, let us know at support madcad. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. Historical Version s – view previous versions of standard. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances.

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This practice may also be used to characterize semi-finished components for implants. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Search book title Enter keywords for book title search. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM F2459 – 18

This test method is suitable for determination of the extractable residue in metallic medical components. Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. This standard does not purport to address all of the safety concerns, if any, associated with its use.

Link to Active This link will always route to the current Active version of the standard. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. Register for a trial account. This standard does not purport to address all of the safety concerns, if any, associated with its use. This test method recommends the use of a sonication technique to extract residue from the medical component.

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It identifies one technique to quantify extractable residue on metallic medical components.

No items in cart. This test method is also not intended to extract residue for use in biocompatibility testing. Land Use and Development. Please login to your authorized staff c2459 to use this feature.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.

Work Item s – proposed revisions of this standard. No other units of measurement are included in this standard.

New ASTM F Standard Test Method for Extracting Residue

In particular, it does not address substances released during implant resorption, implant coatings, f24599 leachables by design. Active view current version of standard. Are you sure you want to empty the cart? Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.

Click here to download full list of books. Copyright Compu-tecture, Inc. This test method is also not intended to extract residue for use in biocompatibility testing. It identifies two techniques to quantify extractable residue on metallic medical components.